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Technical Manager, Ext Quality Job
Eingestellt von Yoh
Gesuchte Skills: Support, Client
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- Perform CMO batch record review in support of lot disposition activities
- Perform the following to drive closure of deviations, change controls, and CAPAs within team
- track receipt of CMO complaint reports by due dates
WHAT YOU'LL BE DOING:
- Collaborate with site management teams, Lot Disposition, Planning, and other stakeholders to meet disposition timelines
- Generate Trackwise reports for team to monitor status Develop and generate metrics to drive on-time closure of records (ie, # of open records, # overdue, etc)
- Support team as needed to drive closure of records, such as followup with SMEs.
- Coordinate PQS implementation activities, Quality Agreement revision timelines, and other quality activities as needed
- Manage communication of product complaints between internal complaint group, CMOs, and site management teams
- Develop, implement and maintain a structure to facilitate communication between site management teams and enable knowledge management within team and dash; for example, a shared folder to store Quality Review Board investigation summaries and quality risk management reports.
- Perform additional activities as required -Investigations, CAPA closures, batch record releases, CC initiation etc.
WHAT YOU NEED TO BRING TO THE TABLE:
- Good communication skills, both verbal and written
- Excellent prioritization, time management, and attention to detail
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Experience with GMP regulations and documentation review (5 (five) years), preferable experience with aseptic processing documentation
- Bachelors degree
WHAT ARE YOU WAITING FOR? APPLY NOW!
RECRUITER: Salima Hakim
Yoh, a DayJ2W: CLINICAL
MONJOBJ2WPACNW
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
South San Francisco, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges